. 2014 Jul 21;6:79–89. doi: 10.2147/RRU.S43125

Table 3.

Adverse events by dose in randomized clinical trials

Adverse event	Dose/group					Control group
Adverse event	50 U	100 U	150 U	200 U	300 U	Control group
Retention PVR >200 excluding those who needed CIC		33/111 (29.7%)^b (>150 mL at 2 weeks) 9/278 (3.2%)^e 5/274 (1.8%)^f Total: 47/663=7.1%		3/15 (20.0%)^a 6/16 (37.5%)^c 3/122 (2.5%)^d Total: 12/153=7.8%		0/7 (0.0%)^a 7/120 (6.0%)^b 0/18 (0.0%)^c 0/118 (0.0%)^d 1/270 (0.4%)^f Total: 8/533=1.5%
Retention requiring CIC	3/21 (14.2%)^g 3/56 (5.4%)^h Total: 6/77=7.8%	5%, 3%, and 1% at 2, 4, and 6 months, respectively^b 15/278 (5.4%)^e 19/274 (6.9%)^f 1/22 (4.5%)^g 6/55 (10.9%)^h (median 30 days) Total: 47/749=6.3%^*	4/27 (14.8%)^g 10/50 (20.0%)^h (median =57 days) Total: 14/77=18.1%^*	1/15 (6.7%)^a 20/122 (16%)^d 11/52 (21.2%)^h (median =179 days) Total: 32/189=16.9%^*	9/55 (16.4%)^h (median =179 days) Total: 9/55=16.4%^*	0/7 (0%)^a 0/120 (0%)^b 5/118 (4.2%)^d 1/272 (0.4%)^e 2/270 (0.7%)^f 1/31 (3.2%)^g 0/37 (0.0%)^h Total: 8/868=0.9%
Mean increase in PVR, mL	30^h	48^h	75^h	82^a 130^h	62^h	0^a 10^h
Transient weakness				1/122^d		1/118^d
UTI	2/18 (11.1%)^g 19/56 (33.9%)^h Total: 21/74=28.3%^£	40/120 (33%)^b 43/278 (15.5%)^e 56/274 (20.4%)^f 0/19^g 20/55 (36.4%)^h Total: 159/744=21.4%^£	2/22 (9.1%)^g 22/50 (44.0%)^h Total: 24/72=33.3%^£	2/15 (13.3%)^a 7/16 (43.7%)^c 38/122 (31.1%)^d (no antibiotics) 25/52 (48.1%)^h Total: 34/83=41.0%^£	19/55 (34.5%)^h Total 19/55=34.5%^£	2/7^a 16/127 (12.6%)^b 0/18 (0.0%)^c 13/118 (11.0%)^d (no antibiotics) 16/272 (5.9%)^e 14/270 (5.2%)^f 2/23 (8.7%)^g 7/43 (16.3%)^h Total: 70/878=8.0%
Hematuria requiring admission, ED visit, or bladder irrigation			0^a	0^a 1/122^d		1/7^a 0/118^d

Notes:

Brubaker et al;22

Visco et al;43

Sahai et al;20

Tincello et al;25

Nitti et al;10

Chapple et al;26

Denys et al;24

Dmochowski et al;23

comparison made with Fisher’s exact test with 100 U as reference: 50 U, P=NS; 150 U, P=0.0004; 200 U, P<0.0001; 300 U, P=0.0075; all doses compared with placebo, P<0.001

^£

comparison made using Fisher’s exact test with 100 U as reference: 50 U, P<0.01; 150 U, P=0.003; 200 U, P=0.0085; 300 U P=0.0043; all doses compared with placebo, P<0.00001.

Abbreviations: CIC, clean intermittent self-catheterization; ED, emergency department; PVR, post-void residual; UTI, urinary tract infection.